AccessGUDID - DEVICE: Suction Liner (06971092631813)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Liner
Version or Model: YDE suction liner with shutoff filter with solidifying agent 1000ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: YDE0110
Company Name: Shijiazhuang Yuanding Medical Device Co., LTD

Primary DI Number: 06971092631813
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 560446074 *Terms of Use

Device Description: YDE suction liner with shutoff filter with solidifying agent 1000ml

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44942	Suction system canister liner	A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1000 Milliliter

Device Record Status

Public Device Record Key: 4a0e8a30-ad21-4dc4-a3d5-85dfb8a0600e
Public Version Date: October 23, 2024
Public Version Number: 2
DI Record Publish Date: February 28, 2024